Therapy Detail

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Therapy Name Abiraterone + Prednisone
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Abiraterone Zytiga CB7630 Hormone - Anti-androgens 54 Zytiga (abiraterone) inhibits cytochrome P-450c17, resulting in decreased androgen synthesis (PMID: 25560485). Zytiga (abiraterone) is FDA approved for patients with metastatic castration-resistant prostate cancer (FDA.gov).
Prednisone Adasone Dehydrocortisone Adasone (prednisone) is a corticosteroid which functions as an immunosuppressant and anti-inflammatory agent and which may stimulate apoptosis in tumor cells (NCI Drug Dictionary).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03748641 Phase III Abiraterone + Niraparib + Prednisone Abiraterone + Prednisone A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer Active, not recruiting USA | TUR | SWE | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUS | ARG 10
NCT01940276 Phase II Abiraterone + Prednisone Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer Completed USA 0
NCT04787744 Phase II Goserelin Degarelix Relugolix Nilutamide Triptorelin Histrelin acetate Docetaxel + Prednisone Leuprolide Apalutamide Abiraterone + Prednisone Flutamide Abiraterone + Methylprednisolone Bicalutamide Docetaxel Enzalutamide Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT) Recruiting USA 0
NCT02429193 Phase II Enzalutamide Abiraterone + Prednisone Biomarkers of Androgen Response and Resistance In Evolution During a Rising PSA (BARRIER-P) Completed CAN 0
NCT06496581 Phase III Enzalutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisone Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel Abiraterone + Prednisone Apalutamide Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) Not yet recruiting FRA 0
NCT04887506 Phase III Abiraterone + Prednisone Prednisone + TAVT-45 TAVT-45 (Abiraterone Acetate) Granules in Patients With Prostate Cancer Completed USA | SWE | POL | HUN | GBR | FRA | ESP 1
NCT04691804 Phase III Abiraterone + Fluzoparib + Prednisone Abiraterone + Prednisone A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Recruiting USA | POL | HUN | GBR | FRA | ESP | CZE | BEL | AUS 4
NCT04291664 Phase I Abiraterone + Prednisone DST-2970 + Prednisone PK and Dose Escalation and Expansion Study of DST-2970 Terminated USA 0
NCT05276492 Phase I Abiraterone + Prednisone Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose. Active, not recruiting USA 0
NCT05288166 Phase III Abiraterone + Prednisone Abemaciclib + Abiraterone + Prednisone A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer) (CYCLONE 3) Active, not recruiting USA | TUR | ROU | POL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 5
NCT06378866 Phase II Degarelix Goserelin Darolutamide Relugolix Triptorelin Enzalutamide Histrelin acetate Abiraterone + Prednisone Leuprolide Apalutamide Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (DIVINE) Recruiting USA 0
NCT04175431 Phase II Abiraterone + Prednisone Fluciclovine (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study Recruiting USA 0
NCT01688492 Phase Ib/II Abiraterone + Prednisone Ipilimumab Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer Active, not recruiting USA 0
NCT04876651 Phase III Docetaxel Enzalutamide 177Lu-J591 + Abiraterone + Prednisolone Abiraterone + Prednisone 177Lu-J591 + Abiraterone + Prednisone 177Lu-J591 + Enzalutamide Abiraterone + Prednisolone 177Lu-J591 + Docetaxel The Present Study Aims to Compare Patients Who Receive the Investigational Product (177Lu-DOTA-rosopatamab) Plus Standard of Care, in Comparison to Standard of Care Only Recruiting NZL | AUS 0
NCT04446117 Phase III Enzalutamide Atezolizumab + Cabozantinib Abiraterone + Prednisone Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC (CONTACT-02) Active, not recruiting USA | POL | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 10
NCT01576172 Phase II Abiraterone + Prednisone Abiraterone + Prednisone + Veliparib Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer Completed USA 0
NCT06136650 Phase III Abiraterone + Prednisone Dexamethasone + Fludrocortisone + ODM-208 Enzalutamide A Study of MK-5684 Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Recruiting USA | TUR | SWE | SVK | ROU | NZL | LVA | LTU | ITA | ISR | IRL | HUN | GRC | GBR | FRA | EST | ESP | DEU | CZE | BRA | AUS 16
NCT03565835 Phase II Abiraterone + Prednisone Abiraterone With Discontinuation of Gonadotropin-Releasing Hormone Analogues in Metastatic Prostate Cancer Unknown status USA 0
NCT03834519 Phase III Abiraterone + Prednisone Enzalutamide Olaparib + Pembrolizumab Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010) (KEYLYNK-010) Completed USA | NZL | NLD | ITA | ISR | IRL | GBR | FRA | ESP | DEU | CAN | BRA | AUT | AUS | ARG 5
NCT04812366 Phase II Abiraterone + Apalutamide + Prednisone Apalutamide Abiraterone + Prednisone Apalutamide + Atezolizumab Abiraterone + Docetaxel + Prednisone Abiraterone + Niraparib + Prednisone Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer (GUNS) Recruiting USA | CAN 0
NCT04497844 Phase III Abiraterone + Niraparib + Prednisone Abiraterone + Prednisone A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (AMPLITUDE) Active, not recruiting USA | TUR | SWE | POL | NZL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BGR | BEL | AUS | ARG 12
NCT03827473 Phase II Abiraterone + Prednisone Docetaxel Docetaxel or Abiraterone Acetate With ADT in Treating Patients With Metastatic Hormone Sensitive Prostate Cancer (ACADEMIC) Terminated USA 0
NCT06173362 Phase II Darolutamide Abiraterone + Prednisone Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer Recruiting USA 0
NCT06520345 Phase III Abiraterone + Methylprednisolone Docetaxel + Prednisolone Abiraterone + Dexamethasone Docetaxel + Prednisone Abiraterone + Prednisone 177Lu-J591 + Docetaxel + Prednisone 177Lu-J591 + Enzalutamide + Prednisone 177Lu-J591 + Abiraterone + Methylprednisolone 177Lu-J591 + Abiraterone + Dexamethasone 177Lu-J591 + Docetaxel + Prednisolone Enzalutamide + Prednisolone Enzalutamide + Prednisone 177Lu-J591 + Enzalutamide + Prednisolone Abiraterone + Prednisolone 177Lu-J591 + Abiraterone + Prednisone 177Lu-J591 + Abiraterone + Prednisolone The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT GLOBAL) Recruiting USA | AUS 0
NCT05204927 Phase III Abiraterone + Enzalutamide lutetium Lu 177 vipivotide tetraxetan Abiraterone + Prednisone Lu-177-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer Active, not recruiting USA | ITA | FRA | ESP 0
NCT01715285 Phase III Abiraterone + Prednisone A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) Completed TUR | SWE | SVK | ROU | POL | NZL | NLD | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BGR | BEL | AUS | ARG 11
NCT03012321 Phase II Abiraterone + Olaparib + Prednisone Abiraterone + Prednisone Olaparib Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects Active, not recruiting USA 0
NCT03511196 Phase I Abiraterone + Prednisone Leuprolide Goserelin Triptorelin Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Active, not recruiting USA 0
NCT06320067 Phase III Darolutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Darolutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Docetaxel + Niraparib and abiraterone acetate + Prednisolone Niraparib and abiraterone acetate + Prednisone Docetaxel + Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Apalutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Enzalutamide Apalutamide + Docetaxel Docetaxel + Enzalutamide Apalutamide Abiraterone + Prednisone Darolutamide + Docetaxel A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (STAMPEDE2) Recruiting GBR 0
NCT03419234 Phase II Abiraterone + Prednisone Abiraterone + Cabazitaxel + Prednisone Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Hormone-Sensitive Prostate Cancer Previously Treated With Docetaxel Active, not recruiting USA 1
NCT03706365 Phase II Abemaciclib + Abiraterone + Prednisone Abiraterone + Prednisone A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer Active, not recruiting USA | ROU | NLD | FRA | ESP | DNK | DEU | AUS 3
NCT03649841 Phase II Abiraterone + Prednisone Abiraterone + Prednisone + Radiotherapy Effects of Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Radiation on Prostate Cancer Terminated USA 0
NCT04647526 Phase III Abiraterone + Dexamethasone Abiraterone + Prednisone Enzalutamide PNT2002 Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH) Active, not recruiting USA | SWE | NLD | GBR | FRA | CAN 0
NCT03016741 FDA approved Enzalutamide Abiraterone + Prednisone Cognitive Effects of Androgen Receptor Directed Therapies for Advanced Prostate Cancer Unknown status USA 0
NCT02218606 Phase II Cabazitaxel Abiraterone + Prednisone Multicenter Trial of Abiraterone Acetate With or Without Cabazitaxel in Treatment of Metastatic Castration Resistant Prostate Cancer Completed USA 0
NCT03833921 Phase II Abiraterone + Prednisone Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer (APRE) Recruiting USA 0


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